Implants, patches and creams also on the way

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SEATTLE, Oct. 1, 2003 — — Forty-year-old Scott Hardin says he’s glad that men may soon have a new choice when it comes to birth control. But, he adds, he would not even consider taking a male hormonal contraceptive. Hardin is like many men who are pleased to hear they may have a new option but are wary of taking any type of hormones.

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

“I would rather rely on a solution that doesn’t involving medicating myself and the problems women have had with hormone therapy doesn’t make me anxious to want to sign on to taking a hormone-type therapy,” says Hardin, who is single and a college administrator.

For the first time, a safe, effective and reversible hormonal male contraceptive appears to be within reach. Several formulations are expected to become commercially available within the near future. Men may soon have the options of a daily pill to be taken orally, a patch or gel to be applied to the skin, an injection given every three months or an implant placed under the skin every 12 months, according to Seattle researchers.

“It largely depends on how funding continues. The technology is there. We know how it would work,” says Dr. Andrea Coviello, who is helping to test several male contraceptives at the Population Center for Research in Reproduction at the University of Washington in Seattle.

Coviello and her colleagues have found that a male contraceptive that releases testosterone over three months is potentially a safe and practical method of contraception. The Seattle researchers have been testing a sustained-released, testosterone micro-capsule, which consists of a thick liquid administered by injection under the skin.

“I never had any real noticeable side effects. I didn’t notice any mood changes. I may have put on a little weight,” says Larry Setlow, a 39-year-old computer programmer with a small software company in Seattle. He has taken part in three male hormonal contraceptive clinical trials at the University of Washington and has received both pills and injections.

“They all worked really well and I was able to look at my lab results and see my sperm count drop to zero,” says Setlow.

Finally, it is the man's turn
Women have had the option of a safe, effective and reversible form of contraception since the development of the female oral contraceptive pill in the 1960s.

Female contraceptives use hormones, estrogens and progestins, to shut off the release of eggs to prevent pregnancy. Male hormonal contraceptives work pretty much the same way: hormones, such as testosterone and progestins, are used to turn off sperm production.

“It seemed like I was getting headaches and then there were times when I woke up sweating at night and I had to change my shirt. Other than that, I didn’t have any side effects,” says 45-year-old Quentin Brown, who lives in Los Angeles and has been a volunteer in a study of MHCs at Harbor-UCLA Medical Center in Torrance, Calif.

Brown has been taking hormonal contraceptives for more than a year. He reports no problems with weight gain or acne, two side effects that occurred in earlier versions of MHCs tested in the 1990s.

Brown, who is married and has three children, hopes his kids will one day be able to benefit from the new technology. His would like his son, who is now 17, to one day have the option of taking a male birth control pill. Brown believes many men will see “their pill” as a good idea and will want to use it.

“It is time for men to have some control. I think it would empower men and deter some women out there from their nefarious plans,” says Brown. “Some women are out there to use men to get pregnant. This could deter women from doing this. An athlete or a singer is someone who could be a target and they could put a stop to that.”

Studies conducted by the World Health Organization show that men from many countries around the world would welcome MHCs. The WHO has tested MHCs in hundreds of volunteers in various countries around the world and have not found it difficult to recruit volunteers for their studies. Researchers say many men are very willing to become involved in the studies and are anxious to see a male birth control pill on the market.

A range of choices
Over the past 5 years, researchers around the world have had a great deal of success with male contraceptive pills, patches, implants and creams that deliver various amounts of hormones. It is now believed that an MHC in the form of a daily pill could be available on the market within 5 to 7 years and implants could arrive even sooner.

“An injectible or an implant (similar to Norplant for women) will be the first to be approved. The big studies are now under way,” says Dr. Christina Wang, who is heading up the clinical trials of MHCs at Harbor-UCLA Medical Center.

She and her colleagues have found that a combination of progestin and androgen implants are safe, effective, inexpensive and entirely reversible.

The California researchers have tested several different products in hundreds of men and are also collaborating with investigators in China. A Chinese clinical trial is now under way at 10 different sites across China and includes 1,000 men. The Phase III trial involves a single injection given once every month. Wang hopes to start a similar trial in the United States within the next 2 years.

We are trying to find the best combination with the least amount of side effects and then the least amount of medication that may be required to get the maximum effects,” says Wang.

Wang adds that in some countries, a low-cost, reversible and long-acting form of an MHC could become commercially available within the next 3 years. However, she says it will probably be at least 5 years before one is approved by the U.S. Food and Drug Administration.

Interestingly, Wang says there is now greater interest in this technology than there ever was in the past and there is now more funding available worldwide than ever before.

But will men take it? Some say yes, some say only if their partners make them, and other say they would never even consider it.